NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

They absolutely did not use patient level data

You are right my mistake. That was a copy-and-paste error from another subject I made from posting all day. I apologize, good you called that out.

I rephrase what I was trying to say:
Northwest Biotherapeutics used an External Control Arm (ECA) made from pooled, aggregate-level data of contemporaneous, peer-reviewed randomized controlled trials (RCTs) in glioblastoma. These were not patient-level datasets and not from real-world healthcare settings like EHRs or registries

Despite the above, MHRA’s current draft guidance (May–July 2025) includes this specific line:

“Many of the general principles would be relevant for external controls drawn from other sources, such as previously completed clinical trials.”

This means:
Even if the control arm isn’t derived from RWD (e.g. it's from past RCTs), MHRA explicitly chooses to apply similar standards to such ECAs.
So while NWBO’s ECA is not RWD, it still falls within the regulatory scope outlined in the draft guidance.

Critics (such as ATL) arguing “DCVax-L doesn’t qualify because it didn’t use RWD” are technically right on data source, but wrong in implication. MHRA is saying: “It doesn’t matter whether the control data is from real-world sources or prior RCTs the same bias mitigation and statistical principles apply.”